- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Charles River Laboratories (Wilmington, MA)
- …biotechnology and/or biomedical industry. Working knowledge of computer validation requirements in government regulations including FDA 21 CFR ... We have an exciting opportunity for a Specialist, Global Computer Validation Quality Assurance for Corporate located...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... laboratory, manufacturing, quality) are validated and maintained in compliance with FDA , EMA, and other global regulatory standards. This role involves close… more
- Charles River Laboratories (Wayne, PA)
- …protocols]. + Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity. + Collaborate with cross functional teams ... related field. + _Experience:_ 1-3 years of experience in computer system validation within a regulated industry...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Novo Nordisk (Bloomington, IN)
- …: + Develop qualification strategies and documents for novel systems and products + Computer System Validation : + Competent in multiple system types + Mastery of ... 8 AM - 5 PM Relationships Reports to Manager, Validation Essential Functions + Equipment Validation : +...and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry… more
- Novo Nordisk (Bloomington, IN)
- …and approve deviations relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer system validation ... and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry...other validation technical disciplines, such as equipment validation , computer system validation , and… more
- Astellas Pharma (Sanford, NC)
- …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required Qualifications**… more